Approval of Work involving Higher Risk Microorganisms Policy

This document applies to all staff members and students of the University.

This document seeks to ensure that work involving microorganisms that are able to cause disease in humans (Higher Risk Microorganisms) is carried out safely and that the University maintains its duty of care to staff members, students and the public.

1. All work involving microorganisms defined as higher risk microorganisms must receive prior approval from the University of Auckland Biological Safety Committee (UABSC). This requirement also applies to clinical specimens that have been shown to contain such microorganisms.

2. Applications for work with higher risk microorganisms are to be submitted to the UABSC.

3. A separate HSNO approval will also be required if principal investigators wish to use higher risk microorganisms as hosts for genetic modification. (See policy documents for Low Risk and High Risk genetic modification).

4. All work with higher risk microorganisms must be within the confines of an MPI approved containment facility and comply with any additional controls imposed as a condition of the approval and the Biological Risk Management and Containment standard.

The following definitions apply to this document:

Biological Risk Management and Containment Standard is a set of standard operating procedures and good practice guidelines used to manage the containment of genetically modified organisms (GMOs) and risk biologicals at the University.

Containment facility is a place approved by MPI in accordance with section 39 of the Biosecurity Act, for holding organisms that should not become established in New Zealand.

HSNO means “Hazardous Substances and New Organisms”.

Higher-risk microorganisms are defined (for the purposes of this policy) as:

(1) Risk Group 2, 3 and 4 microorganisms (whether Genetically Modified Organisms (GMOs) or unmodified microorganisms) as defined by the Australian/New Zealand Standard “2243-3:2010 Safety in laboratories Part 3: Microbiological safety and containment” and/or the United States National Institute of Health “Guidelines for Research Involving Recombinant DNA Molecules”

(2) Any microorganism that displays resistance to antibiotics and/or treatments used to clinically treat the microorganism in question.

MPI is the Ministry for Primary Industries.

Staff member refers to an individual employed by the University on a full or part time basis.

UABSC means the University of Auckland Biological Safety Committee.

University means the University of Auckland and includes all subsidiaries.

Definitions of organism risk groups:

AS/NZ Standard 2243-3:2010:

Risk Group 1 (low individual and community risk) – a microorganism that is unlikely to cause human or animal disease.

Risk Group 2 (moderate individual risk, limited community risk) – a microorganism that is unlikely to be a significant risk to laboratory workers, the community, livestock, or the environment; laboratory exposures may cause infections, but effective treatment and preventive measures are available, and the risk of spread is limited.

Risk Group 3 (high individual risk, limited to moderate community risk) – a microorganism that usually causes serious human or animal disease and may present a significant risk to laboratory workers. It could present a limited to moderate risk if spread in the community or the environment, but there are usually effective preventive measures or treatment available.

Risk Group 4 (high individual and community risk) – a microorganism that usually produces life-threatening human or animal disease, represents a significant risk to laboratory workers and may be readily transmissible from one individual to another. Effective treatment and preventive measures are not usually available.

NIH Guidelines for Research involving recombinant or synthetic nucleic acid molecules (USA, 2016):

Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.

Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.

Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

Include the following:

• Hazardous Substances and New Organisms (HSNO) Act 1996
• HSNO (Low Risk Genetic Modification) Regulations, 2003
• Health and Safety at Work Act 2015
• United States National Institute of Health “Guidelines for Research Involving Recombinant DNA Molecules”
• Approval of Work Involving the Development of Organisms with Low-Risk Genetic Modifications
• Approval of Work Involving the Development of Organisms with High-Risk Genetic Modifications
• Biological Risk Management and Containment Standard
• HSNO Approval of Higher Risk Genetically Modified Organisms Policy
• University of Auckland Low-Risk HSNO Approval APP202708
• University of Auckland Low-Risk HSNO Approved user application form
• University of Auckland Low-Risk HSNO Approved user guidelines

Owned by: Deputy Vice-Chancellor Research
Content manager: Ethics and Integrity Manager
Approved by: Vice-Chancellor
Date approved: July 2021
Review date: July 2026